A Follow-up Study of Immune Dysregulation in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

A Follow-up Study of Immune Dysregulation in Patients With COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669248
• Other study ID #: Qilu-20221224-pang
• Status: Recruiting
• Start date: January 3, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Qilu Hospital of Shandong University
• Contact: Jiaojiao Pang, Dr
• Phone: +8618560089129
• Email: jiaojiaopang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In order to detect the immunosuppression status of COVID-19 patients, this study collected blood samples of COVID-19 patients on the 10th, 20th and 30th days after the onset of symptoms, and detected the proinflammatory, anti-inflammatory factors，immunosuppressive marker，immune cells in the blood samples to evaluate the immunosuppression status of COVID-19 patients.

Description:

After SARS-CoV-2 infection, the patient's immune system is overactivated. While the immune cells release a large number of proinflammatory factors, anti-inflammatory response starts at the same time. Anti-inflammatory factors such as IL-4, IL-10, and IL-37 will be compensated to resist the release of proinflammatory factors and prevent the further development of systemic inflammatory response. However, when the anti-inflammatory factor is excessively released, it will cause compensatory response syndrome, leading to immunosuppression. Whether the level of anti-inflammatory factors continues to rise, and whether it will lead to the persistence of later immunosuppression is unknown. Therefore, this study intends to recruit COVID-19 patients, detect the pro-inflammatory and anti-inflammatory factors，immunosuppressive marker，immune cells in 10 days, 20days, and 30days after the symptoms appear, and evaluate the immunosuppression status of patients with COVID-19

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participant is diagnosed with symptomatic COVID-19 by a positive PCR for SARS-CoV-2 or antigen quicktest.

2. Study participant is 18 years of age or older

Exclusion Criteria:

1. Patients with immunosuppression, including HIV infection, hematopoietic stem cell transplantation and high-dose immunosuppressant therapy

2. Pregnancy or breastfeeding

3. Patients receiving chemotherapy or other cancer treatment

Related Conditions & MeSH terms

• COVID-19
• Immunosuppression

Intervention

Diagnostic Test:
• mid covid-19 patients
Collect the patient's whole blood for testing

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concentration of inflammatory markers (IL-1ß?IL-2? IL-2R ?IL-4 ? IL-6 ? IL-8? IL-10 ?IFN-??TNF-a ?VEGF, etc.) in peripheral blood.		10, 20, 30days
Primary	The concentration of immunosuppression makers(HLA-DR, PD-1, TIM-3,etc.) in peripheral blood.		10, 20, 30days
Primary	The number of immune cells(Th1/Th2 cell, Treg cell, MDSCs,etc.) in peripheral blood.		10, 20, 30days